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K Number
K060684
Device Name
ADPER PROMPT, ADPER PROMPT L-POP
Manufacturer
3M ESPE AG DENTAL PRODUCTS
Date Cleared
2006-04-24

(40 days)

Product Code
KLE
Regulation Number
872.3200
Type
Traditional
Panel
DE
Reference & Predicate Devices
K040857,K962785
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

Bonding between dentin/enamel and composite filling materials Bonding between dentin/enamel and compomer filling materials Bonding mediator for fissure sealing Desensitization of hypersensitive areas of teeth Bonding between RelyX™ Fiber Post root posts and light-curing composite core build-up materials

Device Description

Adper Prompt/Adper Prompt L-Pop is classified as Resin tooth bonding agent (21 C.F.R. §872.3200) because it is a device intended to be painted on the interior of a prepared cavity of a tooth to improve retention of restorative materials (compomer and composite restorative material). Additionally, Adper Prompt/Adper Prompt L-Pop can be used to scal dentinal tubules of exposed root surfaces to prevent from dentinal hypersensitivity. Furthermore, as recent results show, Adper Prompt L-Pop is suited to bond RelyX™ Fiber Post, glassfiber-reinforced root canal posts by 3M ESPE, to light-curing composite core build-up materials.

AI/ML Overview

The provided text does not contain specific acceptance criteria or a study design to prove that the device meets those acceptance criteria in the format requested. The document is a 510(k) summary for a dental adhesive (Adper Promote/Adper Prompt L-Pop) seeking clearance for a new indication: bonding between RelyX™ Fiber Post root posts and light-curing composite core build-up materials.

Instead of presenting quantitative acceptance criteria and a detailed study report, the document states:

  • "Performance and comparative testing of Adper Prompt/Adper Prompt L-Pop has been carried out."
  • "The results suggest that Adper Prompt/Adper Prompt L-Pop is a suitable agent for bonding between RelyX Fiber Post root posts, by 3M ESPE, and light-curing composite core build-up materials."
  • "The data provided in this 510(k) submission shows that Adper Prompt/Adper Prompt L-Pop is substantially equivalent to the predicate devices."

The document focuses on substantiating substantial equivalence to a predicate device rather than providing a detailed performance study against predefined acceptance criteria for the new indication. Therefore, I cannot extract the information required for the table and bullet points as it is not present in the provided text.

§ 872.3200 Resin tooth bonding agent.

(a)
Identification. A resin tooth bonding agent is a device material, such as methylmethacrylate, intended to be painted on the interior of a prepared cavity of a tooth to improve retention of a restoration, such as a filling.(b)
Classification. Class II.